Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
研究概览
简要总结
The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is:
Is PEEPS more effective than Education in decreasing pain interference?
Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life.
Participants will:
- Complete baseline quality of life surveys
- Participate in an 8-session group care program
- Provide feedback on each session and the program globally
- Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion.
- A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-48 years
- •Operative confirmation of endometriosis
- •Chronic pelvic pain (pain perceived to originate from the pelvis, not exclusively during menses, lasting ≥6 months)
- •No plan to have surgery before or during the PEEPS cohort
- •Able to attend at least six of the eight 2-hour weekly sessions on the Washington University campus
- •Comfort reading and speaking English as groups and materials are in English
排除标准
- •Currently pregnant
- •Severe physical impairment (limiting yoga participation)
- •History of hip or spine surgery given increased risk of harm and need for extensive activity modification
- •Current or history of psychiatric disorder with psychosis in order to minimize risk of adverse mental health effects to participants
- •Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
- •History of surgical removal of bilateral ovaries
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a
时间窗: Baseline, immediately after the intervention
Validated, 8-question survey that assesses pain interference in daily activities
次要结局
未报告次要终点